The safety of ultrasound exposure is very important for a patient’s well-being. High-frequency (1–10 MHz) ultrasound waves are highly absorbed by biological tissue and have limited therapeutic effects on internal organs. This article presents the results of the development and application of a low-frequency (20–100 kHz) ultrasonic transducer for sonication of biological tissues. Using the methodology of digital twins, consisting of virtual and physical twins, an ultrasonic transducer has been developed that emits a focused ultrasound signal that penetrates into deeper biological tissues. For this purpose, the ring-shaped end surface of this transducer is excited not only by the main longitudinal vibrational mode, which is typical of the flat end surface transducers used to date, but also by higher mode radial vibrations. The virtual twin simulation shows that the acoustic signal emitted by the ring-shaped transducer, which is excited by a higher vibrational mode, is concentrated into a narrower and more precise acoustic wave that penetrates deeper into the biological tissue and affects only the part of the body to be treated, but not the whole body.
Background and objectives: tremor is an unintentional and rhythmic movement of any part of the body that is a typical symptom of Essential Tremor (ET). ET impairs the quality of life of patients and is treated with pharmacotherapy. We investigated the tremor reduction efficacy of an innovative vibrational medical device (IMD) in ET patients. Materials and Methods: we conducted a prospective, single-center, single-arm, pragmatic study in ET patients with an extended safety study to evaluate the efficacy and safety of the Vilim Ball—a local hand-arm vibration device that produces vibrations in the frequency range of 8–18 Hz and amplitude from 0 to 2 mm. The primary endpoint was the decrease in the power spectrum after device use. The secondary endpoints were safety outcomes. Results: In total, 17 patients with ET were included in the main study, and no patients withdrew from the main study. The tremor power spectrum (m2/s3 Hz) was lower after the device use, represented as the mean (standard deviation): 0.106 (0.221); median (Md) 0.009 with the interquartile range; IQR, 0.087 vs. 0.042 (0.078); Md = 0.009 with the IQR 0.012; Wilcoxon signed-rank test V = 123; and p = 0.027. Seven patients reported that vibrational therapy was not effective. Two patients reported an increase in tremor after using the device. In the extended safety study, we included 51 patients: 31 patients with ET and 20 with Parkinsonian tremor, where 48 patients reported an improvement in tremor symptoms and 49 in function. No serious adverse events were reported, while two patients in the Parkinsonian tremor group reported a lack of efficacy of the proposed medical device. Conclusions: the device reduces essential tremor in some patients and is safe to use in ET.
4 February 2021 in DARU Journal of Pharmaceutical Sciences
The fundamental cause of diabetic limbs’ problem is insufficient blood supply. The aim of the current work was to experimentally and numerically investigate the blood flow velocity and pressure changes in the channel during vibrational excitation. Th
This pilot study gives evidence on the effect of low frequency 2-10 Hz vibration on young physically inactive subjects and associations with blood flow in limbs. For the study purposes, low frequency 2-10 Hz vibration was applied for the subjects in the lying position, and a special device, patented at Kaunas University of Technology, was used to generate low frequency vibrations. Altered temperatures in feet were measured with a thermovisual camera, which records thermal changes. Thermovisual measurement was performed in a warm room (20-21 °C). The entire procedure lasted 45 minutes. Thermovisual measurement was performed 15 minutes before vibration, 15 minutes during vibration and 15 minutes after vibration. For temperature analysis, 2 points on the subjects’ feet were chosen: the central point on the foot where the highest temperature was taken and the peripheral point on the foot where the lowest temperature was measured. Heart rate variability was measured by the Elite HRV programme. The data analysis of temperature in both the central and the peripheral points of the foot under low frequency 2-10 Hz vibration showed insignificant changes in temperature and blood flow; however, the differences determined were insignificant. The assessment of heart rate variability demonstrated that there were statistically significant differences before, during and after vibration. A tendency of the heart rate to increase shows that the heart also reacts to any changes when peripheral blood flow in feet is affected. A reverse dependence was determined: low temperature in the foot increases heart rate variability and, vice versa, increasing temperature decreases heart rate variability. It would be expedient and useful to conduct results with those of healthy subjects.
The present study aimed to investigate the effect of a H2S donor, GYY 4137, on human pulmonary arteries and whether low-frequency ultrasound (20 kHz, 4 W/cm2) inhibits GYY 4137 contractions. Functional studies were conducted on human and rat pulmonary arteries mounted on microvascular myographs. We placed an ultrasonic gadget in the tissue organ bath to insonate the arteries with low-frequency ultrasound. To measure the effect of the low-frequency ultrasound on the entrance of extracellular Ca2+, the preparations were placed in a Ca2+-free solution, and the thromboxane agonist, U46619, and extracellular calcium were added in the presence of insonation. In isolated human pulmonary arteries, GYY 4137 induced contractions, which were most pronounced in the arteries contracted with the thromboxane analogue, U46619. The transient GYY4137 contractions were reversed by low-frequency ultrasound, a blocker of KV7 channels, XE-991 (10 µM), and glibenclamide (1 μM), a blocker of ATP-sensitive channels. Low-frequency ultrasound also inhibited the contractions induced by the smooth muscle entrance of increasing extracellular calcium concentrations. The present findings show that GYY 4137 can cause a transient contraction of pulmonary arteries in human arteries. GYY 4137 alone does not cause significant vascular contraction in rat lung arteries, but it contracts rat lung arteries precontracted with U46619. The transient contractions induced by GYY 4137 can be inhibited by low-frequency ultrasound, probably by counteracting the influx of external Ca2+. The effect of low-frequency ultrasound counteracts contraction in pulmonary arteries; therefore, a possibility could be to develop a larger device allowing treatment of patients with pulmonary hypertension.